Dabigatran lawsuits at 2,000 and rising

Boehringer Ingelheim is facing lawsuits in the United States over claims that dabigatran etexilate mesylate (Pradaxa) capsules causes severe and fatal bleeding. Dabigatran is a blood-thinner used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

At issue

The dabigatran litigation involves approximately 2,000 lawsuits, most of which are consolidated for pretrial purposes in a multidistrict litigation in federal court in the Southern District of Illinois, said Marjorie Moeling,
director, public relations and communications, Boehringer Ingelheim.

“It principally involves an allegation - which we vigorously reject - that the company failed to adequately warn of the risks of bleeding in patients with nonvalvular atrial fibrillation who are taking Pradaxa to reduce the risk of strokes,” Moeling said. “We intend to defend the company against these product-liability lawsuits and are confident that the evidence will show that Boehringer Ingelheim acted appropriately and responsibly in the development and marketing of Pradaxa.”

Prior knowledge?

In a recent New York Timesarticle, it was revealed that Boehringer Ingelheim employees were concerned about the release of internal research showing that some patients taking dabigatran might benefit from regular monitoring of blood, because some individuals absorb too little of the drug to prevent strokes and some absorb too much and are at risk of bleeding. One of the main selling points for dabigatran and its competitors rivaroxaban (Xarelto) and (apixaban) Eliquis has been that these newer anticoagulants don’t require regular blood tests as has the older treatment warfarin. 

According to The New York Times article, an e-mail sent by a Boehringer Ingelheim employee and included among court documents expressed concern that publication of the in-house research would “be especially harmful in the discussions with regulatory bodies” and asked “Can’t this be avoided?”

The research, led by Paul A. Reilly, a clinical program director of Boehringer Ingelheim, was recently published in the Journal of the American College of Cardiology. In it, Reilly noted that “individual benefit-risk might be improved by tailoring the dabigatran dose after considering selected patient characteristics,” such as age.